BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIRWAY PRESSURE MONITOR

    MDR report key: 589359 · Received April 8, 2005

    Report

    Report Number
    2518422-2005-00028
    Event Type
    Death
    Date Received
    April 8, 2005
    Date of Event
    March 3, 2003
    Report Date
    March 11, 2005
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CAP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    LEGAL DOCUMENTATION RECEIVED ALLEGED THAT THE DEVICE WAS IN USE BY A TRACHEOSTOMY PATIENT IN CONJUNCTION IWTH A FREE-STANDING C-PAP, INCLUDING A HEATED HUMIDIFIER, AN OXYGEN ANALYZER MONITOR AND AN OXYGEN AND AIR COMPRESSOR. CPAP WAS BEING ADMINISTERED INVASIVELY. THE INFORMATION ALLEGES THAT THE PATIENT'S TRACH TUBE BECAME DISLODGED AND THE SUBJECT DEVICE DID NOT ALARM AT THE TIME OF THE EVENT. THE PATIENT WAS HOSPITALIZED AND LATER REPORTEDLY EXPIRED FORM ANOXIC ENCEPHALOPATHY. ADDITIONAL PATIENT HISTORY AND A COPY OF THE CORONER'S REPORT ARE UNKNOWN. THE EQUIPMENT AND ALARM SETTINGS AT THE TIME OF THE EVENT ARE UNKNOWN. AN EVALUATION OF THE UNIT HAS NOT BEEN PERFORMED AT THIS TIME AND EFFORTS TO OBTAIN THE EQUIPMENT HAVE BEEN UNSUCCESSFUL. IT IS UNKNOWN AT THIS TIME WHETHER A DEVICE FAILURE HAD ACTUALLY OCCURRED, AND WHETHER THERE WAS ANY ASSOCIATION BETWEEN THE USE OF THE DEVICE AND THE PATIENT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRWAY PRESSURE MONITOR MONITOR, AIRWAY PRESSURE CAP RESPIRONICS, INC. 332259 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death NELLCOR PULSE OXIMETER, OXYGEN AIR COMPRESSOR,| HEATED HUMIDIFIER